Image: JoNel Aleccia
By JoNel Aleccia Health writer
updated 7/1/2011 6:13:18 PM ET 2011-07-01T22:13:18

Federal health officials are investigating whether contaminated alcohol prep products from a shuttered Wisconsin firm led to the death of a 66-year-old man who developed a bacterial infection after being treated for skin cancer and diabetes.

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The death is among eight reports of fatalities, 11 infections and nearly 250 other problems now associated with medical products manufactured and distributed by the Triad Group and H&P Industries Inc. of Hartland, Wis., newly released records from the federal Food and Drug Administration show.

The death is the second fatal report to the FDA that specifically cites a rare infection with the bacteria Bacillus cereus in a patient who used Triad Group alcohol prep pads. Last month, the Wisconsin firm was legally barred from making or distributing the products because of potential contamination with that life-threatening bacteria. has been investigating since February problems with Triad products and with FDA oversight of the potentially contaminated medical supplies used by millions of people in the United States and abroad. See the full series of stories here.

The man was receiving outpatient radiation for squamous cell skin cancer, and he had used home testing supplies to monitor diabetes when he developed a blood infection, the report by the FDA Office of Surveillance and Epidemiology showed. No other details were included.

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The first death report that cites Bacillus cereus infection was submitted on behalf of Harrison Kothari, a Houston toddler whose case sparked investigation into whether Triad products included in a massive January recall were responsible for serious infections. The 2-year-old's parents have filed a lawsuit claiming that contaminated Triad wipes led to the child’s fatal case of meningitis last year. Both that death and the 66-year-old man's death are part of an ongoing review, the FDA said.

Six other death reports submitted by patients’ family members or their doctors question the role of Triad medical products without citing specific bacteria, according to a review of reports from Jan. 6 to June 28. Such reports are difficult to confirm because they don’t include enough information to guide investigators, said Shelly Burgess, an FDA spokeswoman.

Officials with the Triad Group and H&P Industries Inc. have repeatedly said that no deaths or injuries have been confirmed to be caused by their products. Christy Maginn, a spokeswoman for the firm, said that the company hadn't seen the FDA reports and couldn't comment on the specific cases.

Last month, federal officials filed a permanent injunction barring the Wisconsin sister firms from manufacturing or distributing any products because of the potential of life-threatening bacterial contamination.

The records show that the FDA has received reports of 11 non-fatal infections tied to Triad alcohol prep wipes. They include eight related to the alcohol prep products; among those are five that specifically cite Bacillus cereus. In one instance, a hemophiliac patient developed a Bacillus cereus infection and the wipes tested positive for the bacteria, records show. The three other reports cite different pathogens.

In addition, the FDA received one report of an infection caused by the bacteria that forced the March recall of hundreds of thousands of povidone iodine prep pads manufactured and distributed by the Wisconsin firms. The rare bacterium Elizabethkingia meningoseptica was detected in the blood of an infant with a central venous catheter. A Triad povidone iodine swab stick had been used to clean the skin before the line was inserted, the report said.

The agency also received two reports of infections related to recalled sterile lubricating jelly used in medical exams.

In addition, the FDA received nearly 250 reports of other minor problems such as swelling at the injection site, redness, nausea and vomiting.

An ongoing investigation revealed that the FDA knew about problems with contamination and sterilization of the alcohol prep pads and other products dating back to at least 2009. It’s not clear how long the agency has suspected problems with Bacillus cereus because FDA heavily redacts inspection documents. However, redactions challenged by the Milwaukee Journal Sentinel newspaper showed that FDA documented the bacterium in a multi-week inspection that began Nov. 29, 2010.

Under pressure, FDA officials told two U.S. senators that the agency should have issued a warning letter to H&P Industries Inc. and the Triad Group last summer instead of allowing the company to voluntarily comply.

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